FILT-R-ALL BACTERIAL FILTER

Filter, Bacterial, Breathing-circuit

INHALATION PLASTICS

The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Filt-r-all Bacterial Filter.

Pre-market Notification Details

Device IDK896832
510k NumberK896832
Device Name:FILT-R-ALL BACTERIAL FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant INHALATION PLASTICS 7790 N. MERRIMAC Chicago,  IL  60648
ContactJames Lekkas
CorrespondentJames Lekkas
INHALATION PLASTICS 7790 N. MERRIMAC Chicago,  IL  60648
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-05
Decision Date1990-01-22

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